Webinar - Introduction to the new Clinical Trial Regulation
Join our Insider Talk to get up to speed with the CTR as we go through the new concepts, differences between the CTD and CTR, introduce the Clinical Trial Information System (CTIS), and provide guidance on submitting under the regulation.
The new Clinical Trial Regulation (CTR) went live on 31st January 2022 bringing with it significant changes to how clinical trials are submitted and run in Europe.
We are currently in the transition period where the Sponsor can choose whether to submit their clinical trial through the old Clinical Trial Directive (CTD) or under the new regulation. However, the end of the transition period in January 2023 is fast approaching and more sponsors are now considering initiating their clinical trial applications under the CTR.
Learning Objectives:
• Quick recap of the current landscape under the CTD
• Introduction to the CTR
• Outline some differences between the CTD and CTR
• Introduction to CTIS
• Regulatory submissions under the CTR